OSR#1: Industrial chemical or autism treatment?

26 Jan

The Chicago Tribune has added another chapter to their ongoing series posing difficult questions to the autism alternative medical community. OSR#1: Industrial chemical or autism treatment?, by Trine Tsouderos demonstrates the very low standards the alt-med community is willing to accept, at least when it comes to “supplements”.

OSR#1 is being marketed as a supplement by Boyd Haley, retired professor of Chemistry from the University of Kentucky. The chemical used is a powerful chelator, which will come as no surprise to those familiar with Dr. Haley’s history as a proponent of the mercury causation theory in autism. However, “chelation” is not mentioned in the marketing for OSR#1.

Trine Tsudorous has a style I like. She asks very tough questions, points the spotlight on questionable practices and backs up her stories with quotes from experts in the field.

One of the biggest questions raised about OSR#1 is whether the appropriate safety testing has been performed. The marketing doesn’t mention that the chemical used is a chelator.

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Note that CTI Science used to be called “Chelator Technologies, inc”. The chemical used in OSR#1 was invented (and patented) by a colleague of Dr. Haley’s at the University of Kentucky. According to the Tribune story, the original purpose of the chemical was to chelate “heavy metals from soil and acid mine drainage.”

Why would someone avoid calling a chelator a chelator? Especially in the autism alternative-medical community which has been led to believe that chelation is a valid treatment for autism? It appears that chelators are drugs and, as such, are subject to much more stringent and costly safety and efficacy testing than supplements. Dr. Haley is quoted as describing the chemical as “a food”. To my knowledge, this chemical is not found in nature and is not an extract from some food but, rather, a synthetic compound.

From the FAQ for OSR#1

Is OSR#1® a natural compound?

OSR#1® is a combination of two natural compounds that are non-toxic.

Perhaps I missed something–but either this is dodging the question or this is an admission that OSR is not a natural compound. However, either way the wording is carefully chosen.

Ms. Tsuderous brought in an expert on antioxidants for her story as w ell.

“I would worry a lot about giving anything to a small child that hasn’t been scrutinized for both safety and efficacy by the FDA,” said antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine.

Which brings up the question, has the safety and efficacy been scrutinized by the FDA? From the Tribune story:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

But the law does require makers of supplements containing new dietary ingredients — such as OSR#1 — to establish that the product can be expected to be safe.

In June 2008, an FDA senior toxicologist sent a letter to Haley that questioned on what basis the product could be expected to be safe and could be considered a dietary ingredient. According to FDA spokeswoman Siobhan DeLancey, Haley has not responded to the request for more information.

DeLancey declined to discuss OSR#1 specifically, but she said the government prohibits companies from selling a product until the safety requirement is satisfied. Penalties can include warning letters, seizure of products or criminal prosecution. DeLancey said she did not know of any actions taken against Haley or his company.

Haley did not respond to questions from the Tribune about the FDA.

Well, Dr. Haley hasn’t responded to the request for more information. He could face…a warning letter. Sorry, that just summons up images of Michael Palin doing the “Spanish Inquisition” sketch from Monty Python. So far the FDA seems to have let this case slide for over a year, and should they focus attention on OSR#1 and find fault they might issue a “warning letter”? Has the FDA no teeth?

Some of the questions that arise in my mind reading this article are:

1) Is OSR#1 a chelator?
2) is it being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug?
3) is the level of safety testing OSR#1 has undergone appropriate?
4) are the customers for OSR#1 buying it as a chelator or as an antioxidant/supplement?

Let’s take a look at these questions

First, is OSR#1 a chelator? It appears the answer is a fairly clear Yes:

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Second, is OSR#1 being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug? I don’t think we can tell the motivations of Dr. Haley or his company. However, the Tribune story seems to ask the same question:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

Third, is the level of safety testing appropriate? Again, the Tribune brings up the question of whether the FDA has had all its questions answered, even for the lower standard of a supplement.

While not directly on point as to the safety testing, two quotes from the Tribune story stick in my mind when it comes to safety/efficacy:

Ellen Silbergeld, an expert in environmental health and a researcher funded by the National Institutes of Health studying mercury and autism at Johns Hopkins University Bloomberg School of Public Health, said she found the sale of the chemical as a supplement for children “appalling.”

and

“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits,” Grollman said.

Lastly, I posed the question of whether the customers for OSR#1 are buying it as an “antioxidant/supplement” or as a chelator. Again, it is very difficult to ascribe motivations. However, I will point out that in over 400 comments to the Tribune piece, few (if any!) discuss OSR as an antioxidant. Instead there is much discussion of mercury. Rather odd discussion for something that is marketed “only as an antioxidant supplement”.

If you want more details than in the Tribune article, OSR was discussed by Kathleen Seidel of Neurodiversity.com in three articles:

A Fine White Powder

The Industrial Treatment

and

An Inquiry Emerges

Kathleen Seidel is the blogger with the most thoroughly researched articles I have ever seen.

One of the complaints about Ms. Tsudorous’ previous articles, posed by those promoting alternative medical treatments for autism, is that she didn’t seek out “balance”. First, Ms. Tsudorous did enough hard legwork to support her stories without having to rely on pitting parent/advocate opinion on an equal footing with medical experts. Second, Ms. Tsudorous attempted to get comments from a prominent parent/advocate who had publicly touted OSR#1. The parent declined to let her opinion be heard.

The bottom line for this autism parent? OSR#1 doesn’t come close to being something I would give to my child, no matter whether you call it a supplement or a drug. First I side with Dr. Grollman (“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits”). Second, what I have seen of the safety studies doesn’t meet my standards. That’s putting it lightly.

edit to add: the Tribune has posted some of the communications between the FDA and the company selling OSR#1:

Click to access 51678955.pdf

20 Responses to “OSR#1: Industrial chemical or autism treatment?”

  1. Sullivan January 26, 2010 at 09:25 #

    Interesting comment atributed to Dr. Haley:

    “Although DMSA is approved by the FDA Dr. Boyd Haley considers DMSA to be a neurotoxin.”
    http://www.autismone.org/content/my-child-was-disgnosed-autism-spectrum-disorder-now-what

    I haven’t seen much outrage at a neurtoxin being given to autistic children by alternative medical practitioners.

  2. Passing Through January 26, 2010 at 11:20 #

    Autistic children are perfect to test these industrial chemicals on. Just as they are perfect to perform colonoscopies on to see if you can find out the cause of Crohn’s disease.

    I mean, they are not as good as people with Aids, who used to get experimented on in the 80s and 90s because they were going to die anyway, but, I mean, the parents are desperate.

    Hell, they are willing to pay for it.

  3. T Herling January 27, 2010 at 00:59 #

    Just what prevents any snake oil seller from marketing a product as a “supplement” as opposed to its being classified as a drug, and in turn making a lot of money selling it before the FDA catches on?

    And can someone evade the FDA’s drug rules by including some such substance in a capsule with some vitamin, for example?

  4. Fiona June 28, 2010 at 23:48 #

    I am very glad that the FDA is trying to protect these people, even if some of teh high profile ‘advocates’ are blind to the fact that they’re suggesting people poison their kids. Maybe it’ll work in the long run – not more behaviour issues because you get a listless, sick child, like the regular chelation reviews have shown with autism…

    http://www.autismtraining.com.au for some REAL info on therapies

  5. lhs July 22, 2010 at 17:03 #

    “Pumping our kids full of an industrial chemical”. What a joke, look at the ingredients of most vaccines (ignoring thimerosol, which they “recommended” not be added anymore, but are still using up the millions of vials that were produced). Ammonium sulfate – used industrially as a soil fertilizer. Aluminum phosphate – used industrially as a dehydrating agent. Aluminum hydroxide – industrially to manufacture aluminum metal and as a fire retardant. Formaldehyde, MSG…the list goes on of the ingredients that have uses both in medicine and industry. Quite the double standard, these ingredients are ok in our vaccines, but not to help promote/restore health that is potentially lost due to the vaccines.

  6. Chris July 22, 2010 at 17:40 #

    Wasn’t that exact same comment posted here earlier? Dear lhs, so exactly how much formaldehyde are in vaccines compared to what your body makes every day through cell metabolism? At a minimum, vaccines are tested for safety, unlike the OSR.

  7. lhs July 22, 2010 at 20:29 #

    Chris – Take a newborn (only hours old) and give them 5 vaccines, of which cumulatively there is a far greater amount of formaldehyde/formalin (not to mention all the other trash in vaccines) than there little bodies have accumulated, and whose cellular processes, immune systems and ability to rid themselves of toxins are not sufficient to combat this. Most of the formaldehyde produced in humans is due to our bodies converting one compound/substance/toxin into formaldehyde, which is very quickly metabolized into other compounds that are less toxic because if the formaldehyde were to accumulate IT WOULD HARM US. Formaldehyde, according to almost all agencies, is highly toxic and a carcinogen. Why did you just pick formaldehyde out of my post? What about the other “industrial chemicals” in vaccines, that by themselves have been proven to be highly toxic to humans. I guess you add a whole bunch of chemicals that are KNOWN to cause harm in animals/humans, and put them together in a vial, they all cancel each other out. Also, most safety studies on vaccines are worthless, i.e, using vaccines (loaded with trash) as a control in a vaccine study. The list goes on…

    • Sullivan July 22, 2010 at 21:44 #

      “Take a newborn (only hours old) and give them 5 vaccine”

      Would you be so good as to show me which country has a vaccine schedule which includes 5 vaccines on the day of birth.

      I believe Chris may have focused on your use of “formaldehyde” because it is not a defensible position to take. Please, if you would be so good, tell us how much formaldehyde is in the vaccines given on the day of birth (hint, it is only 1), and compare that to the formaldehyde production within the human newborn body.

      Alumimum hydroxide is not the primary ore for manufacturing aluminum metal. That would be aluminum oxide, derived from bauxite. Sodium hydroxide is used in the process. We can go on pointing out that your science is not well founded. But I think Joseph put it best–the difference is that vaccines are tested.

      If you don’t think that the tests on vaccines are sufficient, how can you defend OSR?

  8. Joseph July 22, 2010 at 20:37 #

    Quite the double standard, these ingredients are ok in our vaccines, but not to help promote/restore health that is potentially lost due to the vaccines.

    Two issues:

    1) Vaccines are tested. OSR is not.

    2) Science understands why vaccines work. Science does not know that OSR works as advertised by Haley, and if it did, why.

    That’s the origin of the “double standard.”

  9. lhs July 23, 2010 at 23:00 #

    I apologize, I should have said within the first weeks/months of life. The concern remains, infant immune systems remain very immature and fragile the first several months, even years, of their lives. Around the 2 month mark, they do receive many vaccines, usually at once, and all combined contain a considerable amount of known toxins/carcinogens (many that individually are deemed unsafe at any level for human application). The studies that manufacturers point to in saying that vaccines are “safe” are questionable. Comparing a vaccine to a placebo, which is another vaccine with a “known safety profile”? How was this determined? From another “placebo” i.e., vaccine, controlled study. Most safety figures rely on the physicians voluntarily reporting adverse events via VAERS, which isn’t consistently happening. It leaves it up to individuals as to what constitutes an adverse reaction, which is very subjective. For some, if it doesn’t require a trip to the ER, it’s a normal response. These numbers are then used to prop up the safety record. Most studies will follow side effects for several days or a few weeks. Autoimmune reactions may take several months or years to develop. Those are just a few reasons I don’t think the tests on vaccines are sufficient. I’m not necessarily defending OSR or the tests that were performed, but I do know there were safety trials done. Were they legit? I can’t speak to that. I’m sure if the same compound in OSR were a by-product in a vaccine, it would be just fine. It may not have been proven safe yet, but at least is isn’t a “known human carcinogen” like some of the other by-products or adjuvants already being used.

    • Sullivan July 23, 2010 at 23:45 #

      “The concern remains, infant immune systems remain very immature and fragile the first several months, even years, of their lives.”

      So, wouldn’t that mean that they are more vulnerable to infectious diseases?

      “I’m not necessarily defending OSR or the tests that were performed, but I do know there were safety trials done.”

      There were none performed on humans.

      “I can’t speak to that. I’m sure if the same compound in OSR were a by-product in a vaccine, it would be just fine.”

      What are you saying here? It would be find for you? Since you can’t read my mind, you can’t say that it would be “just fine” by me. As a matter of fact, if you were to say that you would be incorrect.

      “It may not have been proven safe yet, but at least is isn’t a “known human carcinogen” like some of the other by-products or adjuvants already being used.”

      Since it isn’t “known” to be a carcinogen, does that make it OK? Do you (or anyone) have proof that it is not a human carcinogen?

      Could you provide links to the known carcinogens used in vaccines?

  10. Chris July 24, 2010 at 01:40 #

    lhs, please list those toxins and give their exact amounts in the vaccine, plus the studies that show they are bad in any amount.

    Now, as a parent who had a child in and out of the hospital from the time he was two days old until he was almost three years old for various reasons (seizures, croup and seizures from a disease), I am really curious why you think that children do not get exposed to real pathogens in their environment. What is the level of antigen/toxin exposure from vaccines that is higher than what a normal child encounters by just living.

    Now we already know that the argument that formaldehyde is bogus because it is a known by product of human cell metabolism. It is just about as silly as going on about squalene, which is made in your liver as a precursor to cholesterol.

    Now, about aluminum… it is the most abundant metal in this planet’s crust. The most common set of minerals in soil are feldspars, which have aluminum. If you eat food, you will ingest more aluminum than you get in any vaccine (note how one thing you listed is used as fertilizer!). If you breathe air you will breathe in aluminum in floating in the air as dust. The form of aluminum used vaccines is alum, which is commonly used in making pickles.

    Thimerosal has been removed from pediatric vaccines (even influenza vaccines are available without thimerosal). It is used in the manufacturing of vaccines to keep out contamination from bacteria (bacteria are little toxin factories, some of the worst toxins in the world are botulism and the two created by tetanus).

    VAERS is a self-selected survey. The creator of this blog even once posted a report that a vaccine turned his daughter into Wonder Woman, even though he does not live in the USA. It is not an accurate assessment of vaccine safety.

    Now if you have some actual data, and information please post it. You will be ignored if you continue to post unsubstantiated opinions. The data would have to be of this type of quality:

    Mercury Levels in Newborns and Infants after Receipt of Thimerosal-Containing Vaccines
    Pichichero ME, Gentile A, Giglio N, et al
    Pediatrics, February 2008; 121(2) e208-214

    Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
    Thompson WW, Price C, Goodson B, et al; Vaccine Safety Datalink Team
    N Engl J Med, Sep 27, 2007; 357(13):1281-1292

  11. Chuck July 29, 2010 at 10:09 #

    I have used OSR1 a number of times and I think it is really great. As Dr. Klinghardt has mentioned it works especially well when combining it with Biopure’s Phospholipid Exchange. I don’t sense anything toxic about it. The recommended dose is 100mg. I have done 300mg and it is strong at that amount; but, I clearly think that the slight headache I got at 300mg was a good detox reaction not the OSR1 itself. Boyd Haley has done 250mg everyday for a few years with no adverse effects. I myself don’t want to do it every day because it feels like it is working for a few days. He has done tests with rats and worked with a number Dr’s who have used it with patients all before he put it on the market. I thought the Chicago Tribune article was a hatchet job. It is sad to see so much negative press about OSR1. I can only imagine what is behind that mentality. Here is a great video of Boyd Haley:

  12. Dawn July 29, 2010 at 12:39 #

    @Chuck: what detox reaction are you looking for? What “toxins” do you have in your body that your normal chemical processes can’t eliminate? Are you a child, that eats lead paint chips? Do you work in some unregulated industry that does not offer the appropriate protective gear to its employees when working with hazardous items?

    Have you had REAL lab testing that shows you have elevated heavy metals (not the DDI false testing). So strange, people whine and complain about the tested chemicals in vaccines, but take OSR1 which has NEVER had clinical trial testing in humans.

  13. Paul Proffit & Ben GoldDigger May 5, 2011 at 19:16 #

    So people this rigourous testing of vaccines that you speak of ?
    Why therefore is the VAERS database a substantial litany of all the destructive damage that vaccines have done down the years .
    Testing my rear ….. tell that to Zeda Pingel (and dont try the ‘adverse effects are very rare’ routine ! the cause of Autism lies firmly at the fault of vaccines) . Where do you people think Autism springs from , I’d love to hear your creative ideas ? Older Fathers perhaps , vitamin D deficit , sour milk maybe , the Fukushima meltdown. The science is there right now . We know what causes Autism – Vaccines . Its game over for you people who deny the truth.

  14. Kev May 5, 2011 at 19:39 #

    Game over eh? Again? People have been telling us that for about ten years. Still not.

    • Sullivan May 5, 2011 at 19:47 #

      Kev–I’ll be glad if the “game” is over.

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